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Marys pharm notes

Schedule I drugs heroin/lsd, opium
Schedule II drugs hydromorphone, codien, percocet
Schedule III drugs tylenol no 3, anabolic steroids
Schedule IV drugs valuim, lorazepam, xanax
Schedule V drugs robitussion A-C
FDA protects public health by ensuring safety, efficacy, and monitoring of products on the market, regulate drug manufacturing and labeling, adverse reactions, for every 5000 tests only 1 goes thru, very strict approval process
FDA Approval process 1lab and animal testing(up to 3 yrs) 2comp files for investigational new drug 3initiate clinical studies 4. FDA review(203yrs) drug given a brand name 5. FDA approval of new drug(12 years)
Phase one of clinical studies human subjects-volunteer-1 year-goal:evaluate drug metabolism and side effects
Phase two of clinical stuties human subjects-patients(2years)-goal: determine therapeutic effects
Phase three of clinical studies human subjects-patients(3 years)-goals: determine safety and efficacy
Naming of a drug drug can be identified by chemcial name generic name or brand name
Brand name v generic name brand name patented for 17-20 yrs, other companies can use same chemical structure to produce generic(differnt binders) and have abbrev. drug app, generic drugs cost .5 the price of brand name, pharmacists dispense generic if applicable
Classification of Drugs Over the counter, prescription, controlled substance
Over the Counter nonprescription, originally prescription, now approved by FDA, less expensive, less drug per dose
Prescription requires witten script, by loaw must be filled by pharmasist, greater potential for adverse reactions
Controlled substances greater potential for abuse, DEA responsible for over seeing manufacturing, distributrion storage and dispensing
Drug info and recources pharmasists, poison control centers, drug facts and comparision(monthly), physicians dest reference, regulations, prescriptions, banned substances
pharmacists health-care professional traind in the concepts of defining, monitoring, modifying drug therapy, understands action of drugs, uses, doses, drug/food interaction, contraindications
Created by: jwebst1